Clinical trials: Phase 1b
Attention-deficit Hyperactivity Disorder
A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
This is a phase 1b, multicenter, open-label, multiple-dose trial in pediatric subjects (4 - 12 years of age, inclusive) with a confirmed diagnosis of ADHD.
- Trial name
- NCT04786730
- Testing
- Centanafadine
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
High-Grade Glioma
Novel Targeted Radiotherapy in Pediatric Patients With Inoperable Relapsed or Refractory HGG
The purpose of this dose finding study is to evaluate the safety and efficacy of 2 different dose levels of CLR 131 in children, adolescents and young adults with relapsed or refractory high-grade glioma (HGG).
- Trial name
- NCT05610891
- Testing
- CLR 131
- Where
- 8 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Cellectar Biosciences, Inc.
Atopic Dermatitis, Type 1 Hypersensitivity
Allergic Disease Onset Prevention Study
This is a Phase 1b/2, randomized, double-blind, multi-center study to evaluate the safety, tolerability, and preliminary clinical efficacy of STMC-103H in neonates and infants at risk for developing allergic disease (Type 1…
- Trial name
- adored (NCT05003804)
- Testing
- STMC-103H
- Where
- 31 sites in United States, Australia and 1 more
- Volunteers
- 283 people, healthy volunteers welcome
- Sponsor
- Siolta Therapeutics, Inc.
Colitis, Ulcerative
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with…
- Trial name
- NCT01900574
- Testing
- Golimumab
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 35 people
- Sponsor
- Janssen Research & Development, LLC
KCNT1-Related Epilepsy
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of ABS-1230 in Pediatric and Young Adult Participants With KCNT1-related Epilepsy
This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy
- Trial name
- KYRON (NCT07600736)
- Testing
- ABS-1230
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- Actio Biosciences, Inc.
Pelizaeus-Merzbacher Disease
Orbit Study: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intrathecally Administered ION356 in Participants With Pelizaeus Merzbacher Disease (PMD)
The primary purpose of this study is to evaluate the safety and tolerability of ION356.
- Trial name
- NCT06150716
- Testing
- ION356
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 24 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Progressive Pediatric Brain Cancer
Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain Cancer
This is a open label Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme, in…
- Trial name
- NCT07732413
- Testing
- NLG802 (indoximod Prodrug), Temozolomide
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Lumos Pharma
Limb Girdle Muscular Dystrophy, Limb Girdle Muscular Dystrophy Type 2D/R3
Study to Evaluate the Safety, Tolerability, and Efficacy of SRP-9004 Administered by Systemic Infusion in Limb Girdle Muscular Dystrophy Type 2D/R3 Participants in the United States
The primary objective of this study is to evaluate the safety of SRP-9004.
- Trial name
- DISCOVERY (NCT06747273)
- Testing
- SRP-9004
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Sarepta Therapeutics, Inc.
Neoplasms Malignant
Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK)
This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.
- Trial name
- NCT01121588
- Testing
- Crizotinib
- Where
- 21 sites in United States, China and 5 more
- Volunteers
- 44 people
- Sponsor
- Pfizer
Acne Vulgaris
Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-126 Gel in Comparison With Control Gel
This will be an open-label study designed to assess the safety and plasma PK of topically applied IDP-126 Gel compared to Control Gel.
- Trial name
- NCT03653403
- Testing
- IDP-126 Gel, Control Gel
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Bausch Health Americas, Inc.
Respiratory Syncytial Virus Infections
A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV
The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months.
- Trial name
- NCT06102174
- Testing
- Active
- Where
- 9 sites in United States, Japan and 1 more
- Volunteers
- 10 people
- Sponsor
- Pfizer
Spasticity Due to Cerebral Palsy
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild…
- Trial name
- NCT01405950
- Testing
- Zanaflex Capsules
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Acorda Therapeutics
Atopic Immunoglobulin E-Mediated Allergic Disorder
A Phase 1b Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy
The primary objective of this study is to assess the safety and tolerability of STMC-103H compared to placebo in allergic subjects who are otherwise healthy.
- Trial name
- NCT03819881
- Testing
- STMC-103H
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Siolta Therapeutics, Inc.
Metastatic Breast Cancer, HER2-negative Breast Cancer
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
- Conditions
- Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
- Trial name
- TRACY-1 (NCT06590857)
- Testing
- RYZ101, Standard of Care Endocrine Therapy
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 64 people
- Sponsor
- RayzeBio, Inc.
Non-hodgkin Lymphoma
Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab
The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL).
- Trial name
- NCT05206357
- Testing
- Epcoritamab
- Where
- 41 sites in United States, Australia and 12 more
- Volunteers
- 17 people
- Sponsor
- Genmab
Oculopharyngeal Muscular Dystrophy
A Study to Evaluate the Safety and Clinical Activity of Intramuscular Doses of BB-301 Administered to Subjects With Oculopharyngeal Muscular Dystrophy With Dysphagia
Subjects who have enrolled in the oculopharyngeal muscular dystrophy (OPMD) natural history study (Study BNTC-OPMD-NH-001) and have completed at least 6 months of follow up in Study BNTC-OPMD-NH-001 may be eligible to participate…
- Trial name
- NCT06185673
- Testing
- BB-301: Dose escalation phase 1b cohort 1, BB-301: Dose escalation phase 1b cohort 2, BB-301: Dose escalation phase 1b cohort 3
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Benitec Biopharma, Inc.
Retinopathy of Prematurity (ROP)
Safety, PK and PD of FLQ-101 in Premature Neonates
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
- Trial name
- tROPhy-1 (NCT07093255)
- Testing
- FLQ-101
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- FELIQS INC.
Acute Myeloid Leukemia
A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith few options for participants who relapse after treatment or who don't respond to treatment.
- Trial name
- NCT07306832
- Testing
- Pivekimab Sunirine
- Where
- 14 sites in United States, Australia and 5 more
- Volunteers
- 18 people
- Sponsor
- AbbVie
Pediculosis Capitis (Head Lice)
A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
This is an open label, single center, single dose PK study of NatrOVA Creme Rinse (1%), an investigational treatment for head lice and nits, in normal, healthy infants.
- Trial name
- NCT00410709
- Testing
- NatrOVA Creme Rinse (1%)
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- ParaPRO LLC
Neutropenia
A Study of Mavorixafor in Participants With Congenital Neutropenia and Chronic Idiopathic Neutropenia Disorders
This is a 2-part study of mavorixafor in participants diagnosed with chronic neutropenia. The main goal of Part 1 (Phase 1b) is to help researchers learn more about how the investigational medicine, mavorixafor, impacts people…
- Trial name
- NCT04154488
- Testing
- Mavorixafor
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- X4 Pharmaceuticals